Novel technology shows potential to treat heart failure—leading cause of hospitalizations worldwide—with less invasive approach
AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, today announced the closing of a $75 million equity financing co-led by S3 Ventures and RiverVest Venture Partners. This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure). ALLAY-HF is designed to demonstrate the safety and effectiveness of the Alleviant System for the treatment of heart failure through left atrial decompression.
“Alleviant’s mission is to bring a safe, effective no-implant treatment option to millions of patients suffering from heart failure, and this highly informed study is a critical step forward,” said Adam Berman, CEO of Alleviant Medical. “We could not ask for a stronger group of institutional and strategic healthcare investors as we accelerate our global efforts to bring this technology to patients.”
ALLAY-HF is a global prospective, multicenter, randomized, sham-controlled, double-blinded, adaptive trial. The trial will evaluate the safety and effectiveness of the Alleviant System in chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy. The trial will enroll 400 to 700 patients at select sites worldwide. The trial’s composite primary endpoint analysis will be conducted at one year.